fractionated co2 laser with and without clobetasol for treatment of vulvar lichen sclerosus

Conditions: Vulvar Lichen Sclerosus

Summary: this is a randomized placebo-controlled trial design to determine whether combining fxco2-laser with the traditional therapy of clobetasol propionate 0.05% ointment (combined treatment) as compared to fxco2-laser and placebo ointment (fxco2-laser only) will improve treatment response in women undergoing fxco2-laser for vulvar lichen sclerosus. primary objective: to evaluate if women with ls who undergo fxco2 laser therapy and concomitant tcs (clobetasol group) have higher treatment success (defined as a mcid of a ≥16 point improvement in skindex-29 questionnaire) than those who undergo fxco2 laser and placebo ointment (placebo group). * hypothesis: a higher proportion of women randomized to clobetasol will achieve treatment success as compared to those randomized to placebo. * approach: the proportion of women in each cohort who obtain a ≥16 point improvement in skindex-29 validated questionnaire score from baseline to final visit will be compared. secondary objectives: to compare change in pre- and post-treatment scores on validated questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image between the clobetasol group compared to the placebo group. * hypothesis: women randomized to clobetasol will demonstrate an equal or greater improvement on validated quality of life questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image as compared to women randomized to placebo. * approach: change scores will be calculated to determine change per participant over the treatment period and mean change scores will be compared between cohorts.


Eligibility criteria:
inclusion criteria: * women ≥ 18 years old with biopsy confirmed or clinically diagnosed+ ls * english-speaking or spanish-speaking * electing to undergo fractionated co2-laser therapy * willing and able to undergo concomitant 0.05% clobetasol propionate treatment exclusion criteria: * prior surgery with placement vaginal mesh for repair of pelvic organ prolapse (does not include vaginal mesh for anti-incontinence procedure "sling" or prior mesh sacrocolpopexy) * prior laser, topical immunomodulators or systemic therapy for ls * active genital infection\^ * suspicious vulvar lesion that has not been evaluated * known vulvar or vaginal malignancy or active treatment for other malignancy * planning pregnancy or pregnant * prior pelvic radiation therapy * topical corticosteroid use on the vulvovaginal tissues in the past 2 weeks\* * contraindication or allergy to clobetasol propionate 0.05% * currently breast-feeding or lactating * history of poor wound healing, keloids or hypertrophic scarring * history of a skin condition that could interfere with evaluation of efficacy and safety * eligible for inclusion after washout period of 2 weeks \^eligible for inclusion after treatment. for patients with known genital hsv we will instruct them to remain on suppression for the duration of the study.

Keywords: clobetasol propionate fractionated co2-laser